Kornimate/medical-research-clean huggingface dataset:
effectiveness of a diuretic algorithm in clinical stability in heart failure patients

Conditions: Heart Failure

Summary: one of the challenges in treating patients with heart failure (hf) is achieving clinical stability and reducing the hospital readmission rate. a diuretic dose adjustment algorithm developed in the united states (diuretic treatment algorithm, dta) and later validated for use in brazil (as the algoritmo de ajuste de diurético, aad) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. this report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the aad and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with hf.

a probe (prospective randomized open blinded endpoint) parallel-group design will be used. adult patients with a diagnosis of reduced ejection fraction hf, who are being treated at a specialized hf clinic are being recruited. those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial. participants in the intervention group (ig) shall have their diuretic doses adjusted in accordance with the aad and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction). participants in the control group (cg) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls. patients in both groups shall return at 1 month for face-to-face reassessment. the study endpoints shall comprise readmission and/or emergency department visits due to hf decompensation within 90 days and clinical instability. all participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit. overall, 135 patients are expected to be enrolled in each group.

Eligibility criteria:
inclusion criteria: * patients of both genders * age ≥ 18 years * diagnosed with systolic hf * able to monitor body weight at home * using furosemide exclusion criteria: * those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.

Keywords: heart failure therapy diuretics algorithms
implement and test visual consent template and process

Conditions: Cancer; Alzheimer Disease

Summary: the investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. randomization will occur at the research coordinator/research team level. each participating research team member will begin in the standard consent arm of the study. subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.


Eligibility criteria:
eligibility criteria for patients: * adult participants (18+) eligible for one of three participating trials at washington university, university of utah, or university of north carolina at chapel hill. the eligibility criteria for the main trials are below: * unc: * basal-like pdac treated with gemcitabine, erlotinib, and nab-paclitaxel (pangea) trial inclusion criteria: * written informed consent was obtained to participate in the study and hipaa authorization for release of personal health information. * participant is willing and able to comply with study procedures based on the judgment of the investigator. * age ≥ 18 years at the time of consent. * eastern cooperative oncology group (ecog) performance status of 0-1. * consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient. * participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen. * washington university: * returning research results that indicate risk of alzheimer disease dementia to healthy participants in longitudinal studies (weshare) * participants of the knight alzheimer disease research center. * participants with available results from an alzheimer disease blood biomarker test. * participants who agreed to be contacted for additional research studies. * university of utah: * huntsman cancer institute total cancer care * participants who have been diagnosed with any type of tumor or cancer. * participants with genetic predispositions or family history of cancer or tumors. * participant volunteers willing to share samples and data for research. eligibility criteria for research staff: * research staff/coordinators of one of the three participating trials at washington university, university of utah, or university of north carolina at chapel hill.

Keywords: informed consent key information common rule research ethics
text message for adolescents with poorly controlled type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to assess hba1c reduction after supportive care by sms among adolescents with poorly controlled type 1 diabetes.

in 2010, the number of children with type 1 diabetes in france is estimated at 12,000 with 60% of them aged 12 to 17 years. compliance is a major issue during adolescence. mobile text message is one of the strategies to enhance adherence. the main aim of this study is to assess hba1c reduction after a 6 month sms support among adolescents with poorly controlled type 1 diabetes. adherence and quality of life will also be assessed at the end of the trial. this study is a prospective randomized monocentric trial. sixty adolescents with type 1 diabetes and hba1c equal or higher than 8.5 % will be randomized according to the method of zelen in two groups : standard treatment versus standard treatment plus support by sms. the patients will receive one sms before each injection of insulin.

Eligibility criteria:
inclusion criteria: * aged between 12 and 21 years old * with type 1 diabetes for more than 6 months * hba1c at enrollment \> 8.5% * non-opposition of one of the parents * previous medical exam (art. l.1121-11 du csp) * possible follow-up for 6 months * social welfare coverage * adolescents with a mobile phone, able to receive short text message exclusion criteria: * aged less than 12 or higher than 21 years old * with hba1c at enrollment \< 8.5% * pregnancy * psychiatric disease * do not understand french

Keywords: adolescents type 1 diabetes poorly controlled sms improve glycaemic control hba1c reduction poorly controlled type 1 diabetic adolescents
initial clinical presentation of inflammatory optic neuritis associated or not with autoantibodies anti-myelin-oligodendrocyte-glycoprotein

Conditions: Optic Neuritis

Summary: in eight ophthalmic units, the investigator will include all inflammatory optic neuritis (on) during acute phase and rank them in two groups: 1/ on with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (on mog+) 2/ on mog-. the investigators will measure incidence of mog-ab in our prospective population of inflammatory on. then the investigator will compare clinical and radiological presentation of on mog+ versus on mog-.

optic neuritis (on) have a broad clinical spectrum ranging from a single episode (clinically isolated on) to demyelinating diseases such as multiple sclerosis (ms), chronic relapsing inflammatory optic neuritis (crion), acute demyelination encephalomyelitis (adem), neuromyelitis optica (nmo) and neuromyelitis optica spectrum disorder (nmosd). myelin oligodendrocyte glycoprotein (mog) is a myelin antigen exclusively expressed on the surface of oligodendrocytes and myelin in the central nervous system (cns). mog-ab are associated with demyelinating diseases with a good specificity. using cell-based assays, mog-ab were rarely found in healthy control and other neurological inflammatory disease. they were mostly identified in subgroups of nmo/nmosd seronegative to auto antibodies against aquaporin 4 (anti-aqp4): 8-39%, but also in ms (0-28%) adem and idiopathic on. on mog + have a specific clinical presentation compare with on associated with multiple sclerosis (sep): older patient, less female preponderance, more often bilateral, more often optic disc swelling, worse initial visual loss, much more often recurrent with severe sequelae. on mog+ are more similar to on associated with nmosd aqp4+ which have some particularities: similar age, clear female preponderance, less optic disc swelling, more severe initial visual loss and visual sequelae. no prospective study has measured incidence of mog-ab in population of inflammatory on. and no prospective study has ever compared on mog+ with all others inflammatory on. the purpose of our study is to measure incidence of mog-ab in population of acute inflammatory on. all consenting adults with suspicion of on followed in the 8 ophthalmic units who participate will be screened. they will have, as usual, clinical follow-up, blood test with mog-ab research, encephalic and optic nerves mri, and steroid treatment if necessary. at the end of the acute phase, all patients diagnosed with inflammatory on will be included and rank in 2 groups: 1/ on with mog-ab (on mog+) 2/ on without mog-ab (on mog-). clinical data will be register at this inclusion visit. there will be no additional visit and no intervention. after measuring incidence of mog-ab, the investigator will compare clinical and radiological data of on mog+ and on mog-.

Eligibility criteria:
inclusion criteria: * legally adult patient * acute inflammatory optic neuritis * consent exclusion criteria: * patient under tutorship

Keywords: inflammatory optic neuritis autoantibodies anti mog
the utility of thromboelastography in traumatic brain injury

Conditions: Traumatic Brain Injury; Coagulation Disorder

Summary: hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. in this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.


Eligibility criteria:
inclusion criteria: * patients who are delivered to hospital within 24 hours after head trauma * patients whose abbreviated injury score (ais) for other body regions is 3 or less are considered to be isolated traumatic brain injury exclusion criteria: * patients with existing prior neurological disease * patients with known coagulation disorders * patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma * patients receiving blood components prior to blood draw * patients who deteriorate and die before determining whether coagulation- related damage exists

Keywords: thrombelastography coagulation disorder traumatic brain injury coagulation-related damages
an open-label, pilot study to evaluate the efficacy of narrowband ultraviolet-b phototherapy three times weekly for twelve weeks in moderate-to-severe psoriasis patients

Conditions: Psoriasis

Summary: a single center study of 30 patient receiving narrowband uvb phototherapy three times weekly for 12 weeks. patients will be evaluated through week 36 to evaluate maintenance of response.

30 subjects will be treated with increasing doses of narrowband ultraviolet phototherapy three times weekly for 12 weeks. patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

Eligibility criteria:
inclusion criteria: 1. male or female adults ≥ 18 years of age. 2. diagnosis of chronic plaque-type psoriasis for at least 6 months 3. moderate to severe plaque psoriasis as defined by bsa ≥10 pasi ≥12 iga ≥3 4. able to give written informed consent prior to performance of any study related procedures 5. subject is able to attend narrowband uvb phototherapy sessions three times a week and all other protocol specified visits 6. subject must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination. exclusion criteria: 1. forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis 2. history of photosensitivity 3. subject has used ustekinumab and/or anti-il-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first ip dose. 4. use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 5. use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine). 6. patient used topical therapies to treat within 2 weeks of the baseline visit (includes, but not limited to, topical corticosteroids, vitamin d analogs, or retinoids). 7. initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ace inhibitors ) during the trial 8. active infections requiring antibiotics in the 2 weeks prior to baseline 9. patient received uvb phototherapy within 4 weeks of baseline. 10. patient received puva phototherapy within 4 weeks of baseline.
comparison of the safety and immune response of an influenza vaccine made by a new manufacturing process with a vaccine made by the traditional manufacturing process for season 2003/2004

Conditions: Influenza

Summary: the objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, vero cell-derived) at day 21 and day 180 after vaccination.


Eligibility criteria:
inclusion criteria: male and female subjects will be eligible for participation in this study if they: * are \>= 18 and \<= 60 years old (for stratum a only); * are \> 60 years old (for stratum b only); * are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial; * will reliably keep a daily record of symptoms; * understand the nature of the study, agree to its provisions, and give written informed consent; * if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: male and female subjects will be excluded from participation in this study if they: * have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season; * suffer from any kind of immunodeficiency; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; * have a history of inflammatory or degenerative neurological disease (e.g. guillain barré, multiple sclerosis); * have received a blood transfusion or immunoglobulins within one month of study entry; * have a history of any vaccine-related contraindicating event (e.g. anaphylaxis); * have a rash or dermatological condition which may interfere with injection site reaction rating; * have a known or suspected problem with drug or alcohol abuse; * are unable to lead an independent life either physically or mentally; * had administration of an investigational drug within six weeks prior to the study start; * are concurrently participating in a clinical trial; * are pregnant or lactating.

Keywords: influenza vaccine
assessment of the relationship between edema measurement methods after impacted mandibular third molar surgery.

Conditions: Impacted Third Molar Tooth

Summary: the aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.

the patients will be selected among the patients who apply for mandibular impacted third molar extraction to necmettin erbakan university, faculty of dentistry. a total of 60 patients will be included. all third molar operations will be carried out by the same surgeon in all groups with the same technique.two methods will be used to evaluate the edema on the face. 1. method the surgeon will measure from three different places on the patient's face ( two point distance) with the help of a paper ruler. * tragus-pogonion * tragus-labial komissura * angulus mandibula-lateral kantus measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre. 2. method patients will be given edema scale.with the help of the edema scale, the patients will be evaluated the edema by themselves. when the patient stand in front of the mirror, they will be assessed the edema on their face. and a value between 0 and 4 will be pointed on the scale postoperative 2. and 7. days. a correlation between the results of the first and second methods will be examined.

Eligibility criteria:
inclusion criteria: * impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion) * patients with any chronic disease and allergy exclusion criteria: * smoking * pregnancy or lactation * pericoronitis

Keywords: edema third molar
endoscopic optical coherence tomography for screening and diagnosis of colorectal precancerous and malignant polyps

Conditions: Colon Cancer; Rectal Cancer; Cancer of the Rectum; Cancer of the Colon; Precancerous Polyp; Malignant Polyp

Summary: colorectal cancer arises from the mucosal layer of the colon. current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. this method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). optical coherence tomography (oct) using pattern recognition is a high-resolution imaging modality. there is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. the investigators' hypothesis is that oct will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. the investigators will first aim to assess the procedural feasibility and safety of using an oct probe during routine colonoscopy with an early feasibility study. this study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. the eventual goal is to assess the diagnostic accuracy of oct imaging for predicting depth of invasion of colonic tumors.


Eligibility criteria:
inclusion criteria: * undergoing standard of care colonoscopy for the evaluation of colonic polyps. * at least 40 years of age. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * pregnant and/or breastfeeding. * unable to tolerate sedation.
evaluation of the recovery experienced by patients after an ankle sprain treated in the emergency department of nantes university hospital

Conditions: Ankle Sprains

Summary: to evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of nantes university hospital.

the aim of this study is therefore to establish the current situation by describing the practices of doctors working in the adult emergency department of the nantes university hospital regarding the initial treatment of ankle sprains, and to assess the rate of recovery experienced by patients one month after their trauma. this preliminary study may be pursued in the future, with a view to proposing new recommendations for the management of ankle sprains in the emergency department.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * presenting an isolated ankle sprain * visiting nantes chu emergency department for this reason * patient able to read and speak french * patient covered by a social security scheme exclusion criteria: * patient \> 70 years old * patients requiring hospitalization following a visit to the emergency department * any intercurrent pathology that may affect the management of the ankle sprain * associated ankle fracture * patients under legal protection.

Keywords: emergency healing ankle sprain
diabetic gastroparesis efficacy/safety study of tzp-102

Conditions: Diabetic Gastroparesis

Summary: the purpose of this study is to test the safety and effectiveness of 10 mg tzp-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.


Eligibility criteria:
inclusion criteria: * 18 to 80 years of age inclusive * type 1 or type 2 diabetes mellitus * history of symptoms of gastroparesis for at least 3 months leading up to the screening visit * documented delayed gastric emptying * upper gastrointestinal obstruction ruled out by endoscopy or barium scan * concomitant medications must be stable for at least 2 weeks leading up to the screening visit and must be maintained during the study. * females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception exclusion criteria: * gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty * has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the screening visit or during the study * ng, peg or pej feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the screening visit * required parenteral nutrition for treatment of gastroparesis within 2 months prior to the screening visit * active gastric pacemaker within 3 months prior to the screening visit

Keywords: diabetic gastroparesis delayed gastric emptying gastroparesis diabetes mellitus, type 1 diabetes mellitus, type 2